Form 483

6-X Dairy #1 Form 483, 2018-02-22

FDA issued a Form 483 to 6-X Dairy #1 on 2018-02-22 with 2 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds2 observations

6-X Dairy #1 · Modesto, United States · Issued February 22, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

22 Feb 2018
21 CFR 530.11(d)

Tissue residue

Cited by Thomas W Gordon, Rochelle A Rolnik, Tammy Vasquez Hancock, Rochelle R Blair

22 Feb 2018
FDCA 402(a)(4)

Record keeping

Cited by Thomas W Gordon, Rochelle A Rolnik, Tammy Vasquez Hancock, Rochelle R Blair

Inspected site

6D6-X Dairy #1Modesto, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
FDCA 402(a)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere